HIV Infection
Conditions
Brief summary
This is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in HIV infected subject with suppressed plasma viremia.
Interventions
Darunavir/ritonavir (800/100 mg): QD (quaque die )
DRUGLamivudine
Lamivudine (300mg) : QD
DRUGEmtricitabine/tenofovir or abacavir/lamivudine
Emtricitabine/tenofovir (300/200 mg) or abacavir/lamivudine (600/300 mg): QD
Sponsors
Janssen, LP
Fundacion SEIMC-GESIDA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Acceptance to participate in the study, signing the informed consent document before conducting any study procedures. 2. Patient with HIV infection older than 18 years. 3. Treatment with darunavir/ritonavir once a day and tenofovir/emtricitabine or abacavir/lamivudine during at least 4 weeks at the moment of the screening 4. Plasma HIV RNA levels below 50 copies / ml for at least 6 months (two separate measurements at least 6 months with viremia \<50 copies / ml between both). 5. HbsAg negative
Exclusion criteria
1. Pregnant or breastfeeding woman 2. Evidence of Lamivudine resistance (any previous genotype with mutation M184V/I or K65R) and/or to darunavir (population genotype show any of the following mutations: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, T74P, L76V, I84V, L89V). 3. History of virology failure (two consecutive viral loads above 200 copies/ml) while the patient was receiving a regimen with lamivudine or emtricitabine, with the following exceptions: * Do not consider an exclusion criterion if the genotype performed at the time of failure does not demonstrate resistance to lamivudine and darunavir (see criteria 2). * Do not consider an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with undetectable viral load | week 48 | Undetectable viral load \<50 copies/ml according to the FDA snapshot algorithm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with undetectable viral load | Week 24 | Undetectable viral load \< 50 copies/ml according to the FDA snapshot algorithm |
| Proportion of patients with viral load < 200 copies/ml | week 48 | Proportion of patients with viral load \< 200 copies/ml according to FDA snapshot algorithm |
| Proportion of patients who present viral load ≥ 50 copies /ml one time | From basal visit until week 48 visit | Viral load ≥ 50 copies/ml |
| Proportion of patients who present viral load ≥ 50 copies /ml more tan two times | From basal visit until week 48 visit | Viral load ≥ 50 copies /ml |
| Proportion of patients who maintained viral load < 50 copies/ml in all determinations | week 48 | Viral load \< 50 copies/ml |
| Change in renal function | week 48 | Change in glomerular filtration |
| Change in proportion of patients with renal tubular dysfunction | week 48 | — |
| Median of change cells CD4/µl count from basal to week 48 | week 48 | CD4/µl |
| Median of change in triglycerides , LDL-cholesterol, HDL-cholesterol and total cholesterol from basal to week 48 | week 48 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of genotypic resistance mutations | Week 48 | Mutations in patients viral failure |
| Change in proportion of genotypic resistance mutations | week 48 | — |
Countries
Spain
Outcome results
None listed